(123 days)
Lake Region's steerable quidewires are intended for use in anqiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
The attachment of the guidewire extension to the Lake Region Steerable quidewire creates a quidewire that can be used to exchange a catheter without removing the guidewire from the vessel. When the exchange is complete, the quidewire extension can be detached and the original quidewire can aqain be used in a conventional manner.
The quidewire is a steerable PTFE coated stainless steel core wire; the distal portion may be either a 30 cm long stainless steel outer coil with a 2 cm long platinum inner coil to provide radiopacity, or a 30 cm long platinum coil for radiopacity; the tip may be either a straight, shapable configuration or a preshaped J The quidewires are coated with MDX configuration. The quidewires are bound by the following (silicone). parameters:
Outside Diameters: . 014" - . 018" 175 cm - 300 cm Lengths: Straight, Shapable and J Tips: Flexibility: Floppy to Support
The quidewire extension is a PTFE coated stainless steel wire with a connector at the distal end and is bound by the following parameters:
Outside Diameter: .014" - .018" Length: 145 cm
The alignment tool is a slit rubber or silicone cylinder which assists in the placement of the quidewire pin into the extension connector.
The provided K970376 document describes a 510(k) premarket notification for guidewires and accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with specific acceptance criteria directly tied to clinical performance metrics like accuracy, sensitivity, or specificity.
Therefore, the requested information elements related to AI performance, human-in-the-loop studies, multi-reader multi-case studies, and general performance metrics for a diagnostic or AI-driven medical device are not applicable to this submission. This is a submission for a physical medical device (guidewire) where the "acceptance criteria" are based on physical, mechanical, and biocompatibility testing to ensure its safety and effectiveness are equivalent to existing devices.
Here's the breakdown of the information that is applicable based on the provided document:
1. Table of Acceptance Criteria (from physical/mechanical and biocompatibility testing) and Reported Device Performance
For the guidewires, the acceptance criteria are implicitly that the test results fall "within prescribed specification limits" and for biocompatibility, that the tests show no adverse effects. The specific numerical specifications are not provided, only the qualitative results.
| Acceptance Criterion (Test Performed) | Reported Device Performance |
|---|---|
| Dimensional Measurement | All test results were within prescribed specification limits. |
| Distal Tip Flexibility | All test results were within prescribed specification limits. |
| Torsional Integrity | All test results were within prescribed specification limits. |
| Coating Durability | All test results were within prescribed specification limits. |
| Rotational Control | All test results were within prescribed specification limits. |
| Guidewire Pull Test | All test results were within prescribed specification limits. |
| Three Point Bend | All test results were within prescribed specification limits. |
| Extension Joint Coupling | All test results were within prescribed specification limits. |
| Catheter/Extension Joint Interface | All test results were within prescribed specification limits. |
| Extension Joint Integrity | All test results were within prescribed specification limits. |
| Acute Systemic Toxicity | No signs or symptoms of Systemic Toxicity were observed for any of the samples. |
| Cytotoxicity | The sampled passed per current USP. |
| Hemolysis | The samples did not produce hemolysis. |
| Intracutaneous Test | For all samples, skin reactions were not significant. |
| Physico-Chemical | The samples passed per current USP. |
| Thromboresistance | The samples were not considered thrombogenic. |
| Chemical Analyses | The samples meet specifications. |
| Pyrogen test | The products did not produce a pyrogenic response. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Physical/Mechanical Tests: Twenty (20) samples were selected for each product group.
- Data Provenance: The tests were performed by Lake Region Manufacturing, Inc. (LRM). The location and exact time of the tests are not specified beyond the submission date (April 1997). This appears to be prospective testing conducted for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the context of expert consensus is for diagnostic or interpretive devices. For this physical device, the "ground truth" for each test is the objective measurement against established engineering specifications and recognized biocompatibility standards (e.g., USP).
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of interpretations. The tests have objective outcomes (e.g., pass/fail against a specification).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device or a diagnostic device involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical, non-algorithmic device.
7. The Type of Ground Truth Used
- For Physical/Mechanical Tests: Established engineering design specifications (mentioned as "design criteria" and "prescribed specification limits").
- For Biocompatibility Tests: Recognized industry standards and guidance, specifically the FDA's DRAFT "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices" dated May, 1993, and current USP (United States Pharmacopeia) standards.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-driven device that requires a training set. The "training set" for the manufacturing process would be the historical data and experience from the predicate device (previously offered by Baxter).
9. How the Ground Truth for the Training Set was Established
Not applicable for the reason above. The "ground truth" for the manufacturing process is the successful production of functional guidewires meeting specifications, based on established quality systems and processes, and equivalence to the predicate device.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.